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"COMBO-KEY" - A Home Visiting and Phone Coaching Programme to Promote Stroke Survivors' Recovery

25 augustus 2022 bijgewerkt door: Suzanne HS Lo, Chinese University of Hong Kong

"COMBO-KEY" (Coaching Ongoing Momentum Building On stroKe rEcovery journeY) - A Home Visiting and Phone Coaching Programme to Promote Stroke Survivors' Recovery: A Territory-wide Project

Building confidence and capabilities to transfer rehabilitative knowledge and skills into lifestyle-workable strategies for changing health behaviours among stroke survivors are important to optimise health outcomes and reduce risks of recurrent stroke. The aim of this project is to promote stroke survivors' health by building confidence and positive expectations of recovery outcomes, and enabling their engagement in stroke self-management behaviours.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

A randomised controlled trial will be conducted to determine the effectiveness of a programme "Coaching Ongoing Momentum Building On stroKe rEcovery journeY" ("COMBO-KEY"), a home visiting and phone coaching programme, on community-dwelling stroke survivors' self-efficacy, outcome expectation, and engagement in stroke self-management behaviours. An estimated sample of 134 stroke survivors will be recruited. COMBO-KEY will be underpinned by Bandura's constructs of self-efficacy and outcome expectation. It will be delivered by trained coaches. Outcomes will be measured at baseline and immediately after completion of the programme. Generalised estimating equations model will be used to assess the differential changes in outcome variables from pre-test to post-test between the intervention and control groups with adjustment for their baseline levels.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

134

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Hongkong
      • Hong Kong, Hongkong
        • Community settings

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Ja

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

Inclusion Criteria:

  • Clinically diagnosed with stroke
  • 18 years old or above
  • Community dwelling
  • Have a modified Rankin Scale score equal to or greater than 3 (moderate to severe disability)
  • Have a Montreal Cognitive Assessment score >20

Exclusion Criteria:

  • Have severe dysphasia
  • Are diagnosed with a mental illness

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Onderzoek naar gezondheidsdiensten
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Enkel

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: COMBO-KEY group
The participants in the intervention group will receive a home visiting and phone coaching self-management programme (Coaching Ongoing Momentum Building On stroKe rEcovery journeY "COMBO-KEY") which is underpinned by Bandura's constructs of self-efficacy and outcome expectation.
Gedragsmatig: COMBO-KEY
The intervention will last for eight weeks with four home visits and five phone coaching sessions. It will also consist of a 4-item resource package for stroke survivors (including a stroke self-management and self-discovery workbook, a health and life planning toolkit, and videos on sharing of experience by survivors who managed their post-stroke challenges successfully, and a stroke self-management quick reference guide). A telephone hotline for survivors and caregivers to seek information and support related to stroke self-management will also be established. A programme protocol will be developed to ensure the consistent delivery of the programme.
Geen tussenkomst: Usual care group
The participants in the usual care group will receive usual rehabilitation services offered, including services by a community rehabilitation network such as exercise training, physical rehabilitation, or activities organised by stroke support groups.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change in the level of self-efficacy in performing daily functional activities and self management
Tijdsspanne: Change from baseline level to immediately after completion of the intervention
The 13-item Chinese version of the Stroke Self-Efficacy Questionnaire will be used. The items assess the stroke survivors' confidence in performing self-management behaviours over a 0-no confidence to 10-very confident points scale. All item scores are summed (total 0-130). Higher scores indicate higher self-efficacy.
Change from baseline level to immediately after completion of the intervention

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change in the level of outcome expectation of stroke self-management behaviours
Tijdsspanne: Change from baseline level to immediately after completion of the intervention
The 11-item Chinese version of the Stroke Self-management Outcome Expectation Scale will be used. The items assess the stroke survivors' confidence in the occurrence of outcomes after performing the self-management behaviours. All item scores are summed (total 0-110; each item is rated over 0-Strongly disagree to 10-Strongly agree). Higher scores represent higher confidence towards positive outcome.
Change from baseline level to immediately after completion of the intervention
Change in the level of satisfaction with performance of stroke self-management behaviours
Tijdsspanne: Change from baseline level to immediately after completion of the intervention
The 11-item Chinese version of the Stroke Self-management Behaviours Performance Scale will be used. The items ask the stroke survivors' satisfaction with their performance of self-management behaviours. All item scores are summed (total 0-110; each item is rated over 0-Strongly disagree to 10-Strongly agree). Higher scores represent higher satisfaction.
Change from baseline level to immediately after completion of the intervention
Change in the level of health-related quality of life
Tijdsspanne: Change from baseline level to immediately after completion of the intervention
The 49-item Chinese version of the Stroke Specific Quality of Life Scale will be used. The items ask the stroke survivors' agreement to the health conditions and difficulties in performing the tasks described. All item scores are summed (total 49-245; 1-Strongly disagree/couldn't do it to 5-Strongly agree/no trouble). Higher scores represent higher health-related quality of life.
Change from baseline level to immediately after completion of the intervention
Change in the level of depressive symptoms
Tijdsspanne: Change from baseline level to immediately after completion of the intervention
The 15-item Chinese version of the Geriatric Depression Scale will be used. The stroke survivors will be asked for agreement to the items based on their condition (total 0-15; Yes-1 score or No-0 score). A score of 5-8 indicates mild depression; 9-11 moderate depression; and 12-15 severe depression.
Change from baseline level to immediately after completion of the intervention
Change in the level of community reintegration
Tijdsspanne: Change from baseline level to immediately after completion of the intervention
The 11-item Chinese version of the Reintegration to Normal Living Index will be used. The stroke survivors will be asked the extent to which the items described their situation (total 11-55; 1-A small extent to 5-A great extent). Higher scores represent better community reintegration.
Change from baseline level to immediately after completion of the intervention
Satisfaction with the programme (Participants in the intervention group)
Tijdsspanne: Immediately after completion of the intervention
Rate the ease of use and relevance of contents and resources, arrangement, and coaches' performance on a 5-Likert point (1-Very dissatisfied to 5-Very satisfied)
Immediately after completion of the intervention
Usage of the resource package (Participants in the intervention group)
Tijdsspanne: Immediately after completion of the intervention
Frequency (minutes) of using the resource package per week
Immediately after completion of the intervention
Level of goal attainment (Participants in the intervention group)
Tijdsspanne: Immediately after completion of the intervention
Rate the level of goal attainment on a scale from 0-Not attained, 1-Partially attained, to 2-Completely attained
Immediately after completion of the intervention

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Chinese University of Hong Kong

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

1 maart 2019

Primaire voltooiing (Werkelijk)

30 juni 2022

Studie voltooiing (Werkelijk)

30 juni 2022

Studieregistratiedata

Eerst ingediend

12 november 2018

Eerst ingediend dat voldeed aan de QC-criteria

13 november 2018

Eerst geplaatst (Werkelijk)

15 november 2018

Updates van studierecords

Laatste update geplaatst (Werkelijk)

29 augustus 2022

Laatste update ingediend die voldeed aan QC-criteria

25 augustus 2022

Laatst geverifieerd

1 augustus 2022

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 01170718

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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